WO2021178040A1 - Électrode pouvant être enroulée circonférentiellement destinée à être utilisée avec des implants chirurgicaux métalliques - Google Patents

Électrode pouvant être enroulée circonférentiellement destinée à être utilisée avec des implants chirurgicaux métalliques Download PDF

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Publication number
WO2021178040A1
WO2021178040A1 PCT/US2021/010004 US2021010004W WO2021178040A1 WO 2021178040 A1 WO2021178040 A1 WO 2021178040A1 US 2021010004 W US2021010004 W US 2021010004W WO 2021178040 A1 WO2021178040 A1 WO 2021178040A1
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WIPO (PCT)
Prior art keywords
electrode
patient
wrappable
conductive layer
implanted device
Prior art date
Application number
PCT/US2021/010004
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English (en)
Inventor
Jackson G. HOBBLE
Original Assignee
Garwood Medical Devices, Llc
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Publication date
Application filed by Garwood Medical Devices, Llc filed Critical Garwood Medical Devices, Llc
Priority to US17/802,709 priority Critical patent/US20230134196A1/en
Publication of WO2021178040A1 publication Critical patent/WO2021178040A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4675—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for cleaning or coating bones, e.g. bone cavities, prior to endoprosthesis implantation or bone cement introduction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00—Layered products comprising a layer of metal
    • B32B15/02—Layer formed of wires, e.g. mesh
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B15/00—Layered products comprising a layer of metal
    • B32B15/20—Layered products comprising a layer of metal comprising aluminium or copper
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form
    • B32B3/02—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by features of form at particular places, e.g. in edge regions
    • B32B3/08—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by features of form at particular places, e.g. in edge regions characterised by added members at particular parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form
    • B32B3/26—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer
    • B32B3/266—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/18—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by features of a layer of foamed material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B9/00—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00
    • B32B9/005—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00 comprising one layer of ceramic material, e.g. porcelain, ceramic tile
    • B32B9/007—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00 comprising one layer of ceramic material, e.g. porcelain, ceramic tile comprising carbon, e.g. graphite, composite carbon
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B9/00—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00
    • B32B9/04—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00 comprising such particular substance as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B9/041—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00 comprising such particular substance as the main or only constituent of a layer, which is next to another layer of the same or of a different material of metal
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B9/00—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00
    • B32B9/04—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00 comprising such particular substance as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B9/046—Layered products comprising a layer of a particular substance not covered by groups B32B11/00 - B32B29/00 comprising such particular substance as the main or only constituent of a layer, which is next to another layer of the same or of a different material of foam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2266/00—Composition of foam
    • B32B2266/12—Gel
    • B32B2266/122—Hydrogel, i.e. a gel containing an aqueous composition
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2305/00—Condition, form or state of the layers or laminate
    • B32B2305/02—Cellular or porous
    • B32B2305/022—Foam
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2305/00—Condition, form or state of the layers or laminate
    • B32B2305/38—Meshes, lattices or nets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/20—Properties of the layers or laminate having particular electrical or magnetic properties, e.g. piezoelectric
    • B32B2307/202—Conductive
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2405/00—Adhesive articles, e.g. adhesive tapes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses, catheter
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01B—CABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B13/00—Apparatus or processes specially adapted for manufacturing conductors or cables
    • H01B13/0036—Details

Definitions

  • This application is generally related to the field of surgically implanted orthopedic devices, and more specifically to a wrappable electrode used as part of a system to remove biofilm from a metal implant.
  • Metal implants are orthopedic devices or apparatus that are used in patients with many different injuries or medical problems.
  • metal implants may be used for any individual that needs to replace joints.
  • a metal implant may be used to replace a patient’s hips or knees.
  • One potential problem with metal implants is that they tend to allow for the growth of bacteria on the surface. This may increase the patient’s risk for an infection, which could require the potential removal of the implant.
  • electrodes can provide electrical stimulation to disrupt the growth of bacteria.
  • a potentiostat is a stimulating device or instrument used to drive electrical current from a counter electrode to a working electrode in order to keep the voltage on the working electrode at a constant value, as compared to a stable reference electrode.
  • the anode represents the counter electrode and the cathode represents the working electrode.
  • CVCES Cathodic Voltage Controlled Electrical Stimulation
  • the cathode represents the working electrode.
  • a potentiostat a user can dictate which electrochemical process is actually occurring on the working electrode and at what rate it occurs simply by adjusting the applied voltage parameters.
  • the counter electrode has specific physical, electrical, and chemical requirements it must meet in order to sufficiently facilitate CVCES, especially in a clinical environment in which a patient’s health is concerned.
  • the CVCES technique in a clinical setting has been shown as a way to fight bacterial biofilm infections on metallic implants in the most minimally invasive way possible.
  • the patient’s body provides the electrolytic solution and therefore acts as an electrochemical cell by using the metal implant (working electrode) as the cathode and the counter electrode as the anode.
  • the disclosed invention presents a novel way of increasing the efficiency of the treatment of metal implants, while maintaining patient safety parameters and its minimally invasive profile.
  • a wrappable electrode configured for use in an electrochemical system for treating a metal surgically implanted device, the electrode comprising a flexible covering, a lead wire configured for connecting the electrode to a stimulating device, an adhesive layer to enable the electrode to be attached to the skin of a patient, and an inert conductive layer to which the lead wire is electrically connected.
  • the electrode including each of the resident layers, is sized and configured to be wrapped circumferentially about the limb of a patient so as to uniformly and evenly distribute treatment onto a surface of the implanted device.
  • the electrode is substantially wrapped entirely about an entire limb of a patient (arm, leg) having the implanted device, although the electrode can provide improved treatment results by covering at least 50 percent of the limb of the patient.
  • the electrode further comprises another conductive layer disposed between the inert conductive layer and the flexible covering.
  • the latter conductive layer is made from copper, which can be provided, for example, as a mesh or a solid sheet of material. This conductive layer enables better effective electrification upon the inert (anodic) conductive layer of the electrode.
  • the adhesive layer of the electrode can comprise a hydrogel.
  • the hydrogel further comprises a buffering compound.
  • the electrode further comprises at least one feature disposed on the flexible covering configured to align the electrode relative to the patient.
  • the at least one feature aligns the electrode with a known anatomical landmark of the patient.
  • the metal surgically implanted device is preferably a working electrode with the herein described electrode acting as a counter electrode of the electrochemical treatment system, each couplable to the stimulating device that applies an electrical current between the working and counter electrodes.
  • the herein described electrode serves as the anode for the electrochemical reaction and the implant acts as the cathode, enabling biofilm to be removed under the application of a suitable voltage.
  • the herein described electrode can further comprise at least one feature for positioning a separate but proximate reference electrode.
  • the at least one positioning feature comprises a cut-out area formed on the electrode, the cut-out area being sized and configured for placement of the reference electrode.
  • a system configured for treatment of a metallic surgically implanted device, the system comprising a stimulating device capable of providing an electrical current, and an electrode configured for attachment to the skin of a patient in proximity to the metallic surgically implanted device, each of the metallic surgically implanted device and the electrode being electrically coupled to the stimulating device in which the metallic surgically implanted device is a working electrode and the electrode is a counter electrode of a formed electrochemical cell, and in which the electrode is sized and configured to be wrapped circumferentially about a limb of the patient in order to uniformly and evenly provide treatment on a surface of the impanted device.
  • the electrode is configured to be entirely wrapped about the limb (arm, leg), but minimally the electrode can be wrapped at least 50 percent about the limb to provide improved results.
  • the electrode comprises a flexible covering, a lead wire configured for connecting the electrode to the stimulating device of the system, an adhesive layer to enable the electrode to be attached to the skin of a patient, and an inert conductive layer to which the lead wire is electrically attached.
  • the electrode can further comprise another conductive layer disposed between the inert conductive layer and the flexible covering.
  • the latter conductive layer is made from copper and can be provided as a mesh or a sheet in which the conductive layer enables more uniform electrification of the inert (anodic) conductive layer of the electrode.
  • the adhesive layer of the electrode can comprise a hydrogel and according to a preferred embodiment, the hydrogel further comprises a buffering compound.
  • the electrode further comprises at least one feature disposed on the flexible covering that is configured to align the electrode relative to the patient. In at least one preferred embodiment, the at least one feature repeatably aligns the electrode relative to a known anatomical landmark.
  • the herein described electrode further comprises at least one feature for positioning a separate but proximate reference electrode.
  • the at least one positioning feature can comprise at least one cut-out area formed on the counter electrode, the cutout area being sized and configured for placement of the reference electrode.
  • the inert conductive layer can be made from carbon.
  • the inert conductive layer serves as the anode of the electrochemical reaction wherein suitable current is provided by the stimulating device through the coupled lead wire to the electrode.
  • This invention is based on a system in which DC electrical current is applied to a surgically implanted device, such as a knee replacement, in order to electrochemically clear and disrupt harmful bacterial biofilm from the metallic surface.
  • the system requires at least two electrodes to effectively transfer the DC electrical current to the metal implant.
  • One electrode is the implant itself, referred to as the working electrode, which is connected to the stimulating device by mechanical means, such as a needle or other subdermal attachment.
  • the second electrode referred to as the working electrode, is adhered to the skin of the patient.
  • the invention as disclosed is a novel design of the skin-based counter electrode that addresses and improves several problems with the overall system of treatment.
  • One significant feature of the design is that the electrode wraps around the full periphery of the limb. This feature inherently does two (2) things to improve the overall treatment. First and if the skin electrode was a common patch located on one side of the implant, the natural tendency of the electrochemical reaction would become more intense on the side of the implant that is closest to the implant, thereby creating an uneven treatment on the implant.
  • the herein described electrode that preferably covers the entire circumference or at least 50 percent of the limb of the patient in proximity to the implant provides an equidistant or substantially equidistant path for electrical current to every point on the implant, thereby creating an even and uniform distribution of treatment upon a surface of the metal implant.
  • the skin electrode was only on one side of the limb, all of the electrical current directed to the implant would enter the body at a smaller, single area of the skin and tissue.
  • concentrating the current locally all at one spot could potentially cause chemical bums or thermal necrosis to the localized tissue.
  • Using the herein described electrode, however, that covers substantially a majority or more preferably the entire periphery of the limb (i.e., arm, leg) of the patient allows the electrical current entering the body to become much more widely distributed.
  • electrodes are electrically attached via a single point of contact to the lead wire.
  • a single point of contact may require the stimulating device providing the electrical potential to generate larger voltages.
  • an additional conductive layer made preferably from a copper mesh or suitable matrix is embedded behind a chemically inert (carbon) conductive surface layer of the electrode to more evenly spread the point of contact over a larger area.
  • these treatments employed on a surgical implant may further employ a third electrode, referred to as a reference electrode, which is used in conjunction with the working and counter electrodes.
  • the counter electrode further includes at least one feature that is configured to align with anatomical landmarks of the body, such as the patella. These alignment feature(s) provide consistent placement zones for other electrodes in the system in order to provide more consistent treatment in terms of current draw.
  • this invention is unique because it improves treatment outcomes and consistency for a medical procedures relative to surgically implanted devices, whose purpose is to eliminate biofilm infections of the devices.
  • the disclosed invention provides a means to promote an evenly distributed electrical current upon a metal implant, such as the femoral or tibial components of a knee implant to increase treatment consistency and effectiveness.
  • the invention also distributes the anodic current on the skin electrode over a larger area, as compared to other electrode configurations, thereby decreasing the likelihood of harm or injury to the skin or bodily tissue beneath the electrode.
  • the herein described electrode further resolves a need to optimize voltage capabilities of the stimulating device, such as a potentiostat or similar means, through the use of conductive meshes adhered behind the electrode’s conductive surface.
  • the herein described electrode provides consistent placement zones for other electrodes in the electrochemical system to provide more consistent treatment in terms of current draw.
  • FIG. 1 depicts a schematic view of an electrochemical system including a known electrode in conjunction with a surgically implanted device (a metal implant);
  • FIG. 2 depicts a schematic view of an electrochemical system that includes an electrode, which is made in accordance with aspects of the invention
  • FIG. 3 is a diagrammatic view of an electrode made in accordance with aspects of the invention, as attached to an electrochemical system for treating a metal implant;
  • FIG. 4 is a partially exploded view of a portion of an electrode made in accordance with aspects of the invention. Detailed Description
  • the following relates to embodiments directed to an improved and novel electrode design for use in electrochemical systems and processes for treatment of metallic surgically implanted devices (hereinafter also synonymously referred to throughout as “metal implants” or “metallic implants”).
  • metal implants metallic surgically implanted devices
  • metal implants metallic surgically implanted devices
  • the embodiments that are described are to a specific surgically implanted device (knee replacement).
  • the concepts described are applicable to literally any metallic surgically implanted orthopedic device.
  • a number of terms are used throughout this description in order to provide a suitable frame of reference for the accompanying drawings.
  • FIG. 1 depicts a scenario in which a traditional patch (TENS) electrode 100 is placed on one side of the skin 116 of a patient with a small surface area (represented by the short black line) as part of an electrochemical system used to provide treatment of a surgically implanted device and more specifically a metal implant 104.
  • the patch electrode 100 is defined by a local profile (typically about 2” by 2”) having an adhesive layer, an internal conductive layer as well as an outer covering layer.
  • the known patch electrode 100 may include a hydrogel layer as part of the adhesive layer or in some instances be defined by an ultrasound gel beneath a dry carbon layer. Such known electrodes 100 that are typically configured for muscle stimulation.
  • the metal implant 104 is a knee replacement having femoral and tibial components.
  • the metal implant 104 is electrically coupled to a stimulating device 110, such as a potentiostat, which is capable of applying electrical current, using needles or other connection means.
  • the electrical connections between the stimulating device 110 and the metal implant 104 are each diagrammatically shown by lines 114, thereby forming a working electrode (cathode) at the metal implant 104.
  • the number of needles or other connection means attachable between the metal implant 104 and the stimulating device 110 can be suitably varied.
  • electrical connections are also made between the stimulating device 110 and the skin electrode via a lead wire, which in this instance is also diagrammatically shown as 114.
  • the patch electrode 100 is attached adhesively to the skin of the patient on one local side of the leg of the patient and further to the stimulating device 110, and forms a counter electrode (anode) of the treatment system with the patch electrode 100 and metal implant 104 (cathode) forming an electrochemical cell.
  • FIG. 1 represents an idealized cross-sectional view of a leg at the knee where the metal implant 104 is in the center of the joint.
  • the circular region 116 represents the skin, with the shading 120 within the circle 116 representing the flesh, the stars 124 representing anodic current flow, and the stars 128 representing cathodic current flow as applied by the stimulating device 110. It can be seen in this scenario that the stars 128 are clustered heavily on the surface of the metal implant 104 closest to the skin electrode 100, with very few stars 128 on the further sides of the metal implant 104.
  • the distance between the skin electrode 100 and the opposite side of the metal implant 104 increases the natural resistance between the two electrode zones, and thus less electrical current will flow there.
  • FIG. 2 depicts the same leg as in FIG. 1, using the same electrochemically-based treatment system. Similar features are labeled with the same reference numbers, including the same symbols as those previously discussed in FIG. 1 , for the sake of clarity. Both of the stars 124, 128 representing anodic and cathodic current flow, respectively, are in the same quantity in both FIGS. 1 and 2.
  • the stimulating device 110 is electrically coupled via conductive needles or similar means 114 to the metal implant 104, the latter acting as a working electrode of the created electrochemical cell with the counter electrode 200 being attached to the skin of the patient.
  • the counter electrode 200 is sized and configured to be wrapped entirely about the leg of the patient, and more specifically around the entire knee joint peripherally.
  • the counter electrode 200 normalizes the distance between itself and any singular point on the metal implant 104, at least to a much higher degree than in the prior art example of FIG. 1, which therefore creates a near equivalent resistance path from all points on the surface of the metal implant 104. Because of this, the stars 124, 128 that represent the electrochemical reaction become homogeneously dense upon both the surface of the metal implant 104 and the counter electrode 200. Providing an electrode disposed in a wrappable manner therefore provides a more consistent and predictable treatment and disrupts bacterial biofilm found on the implant 104. Consistent treatment is especially important when treating biofilms because, if portions of the biofilm do not receive adequate treatment, as would be the case in FIG.
  • the biofilm is liable to simply regrow and continue to cause infectious issues for the patient.
  • the electrode 200 described herein is designed in a novel way that covers the full periphery of the limb, thereby providing an equidistant electrical current path to every point on the metal implant 104, and creating an even distribution of treatment thereupon.
  • the 200 wraps around at least a majority or more preferably the full circumference of the limb in proximity relative to the metal implant. This feature inherently does two (2) things to improve the treatment of the metal implant 104. First and if the electrode was a common patch located on one side of the implant 104, such as the traditional patch electrode 100, FIG. 1, the natural tendency of the electrochemical reaction will become more intense on the side of the metal implant 104 that is closest to the patch electrode 100, thereby creating an uneven treatment on the implant 104. This behavior occurs because the electrical current applied by the stimulating device 110 will naturally want to flow through the path of the least resistance to the other electrode.
  • FIG.l demonstrates over traditional patch electrodes 100 is shown by side by side examination of FIGS. 1 and 2.
  • the behavior of the stars 124 only i.e., the anodic reaction
  • the skin electrode 100 is installed in this configuration, all of the electrical current interacting with the skin electrode 100 would enter the body in a smaller, singular area of the skin and tissue. Depending on the amount of current entering the body, concentrating it all to one spot could cause severe chemical bums or thermal necrosis to the localized tissue, especially the skin.
  • FIG. 4 depicting a sectioned view of a portion of an electrode 400.
  • This electrode 400 is only partially shown to show the internal construction but is intended to be defined by a wrappable configuration similar to the electrode 200 of FIG. 2 that is sized and configured to be wrapped over a majority (greater than 50 percent) or more preferably the entire circumference of a limb of a patient in proximity to an implanted orthopedic device.
  • the general components of the novel electrode 400 according to this embodiment include a lead wire 404 that extends from a stimulating device such as potentiostat 110, FIGS.
  • the electrode 400 is fabricated with a series of stacked layers that include an adhesive exterior layer 422, made preferably from a fabric, a conductive layer 416, a conductive anodic film or surface layer 412, and a buffered hydrogel 406, in addition to the preferred sizing of the electrode 400 to permit wrapping as previously discussed. Details relating to the operation of the potentiostat 110 are known to those in the field and do not require further explanation as to their use in CVCES treatment systems. Each of the foregoing features, in addition to at least one feature for aligning/locating the electrode on the skin of the patient, are now described in greater detail.
  • One feature of the novel electrode 400 is to help improve patient safety is a buffering system within an adhesive hydrogel that acts to neutralize any acidic pH changes at the electrode to skin interface.
  • a hydrogel is a solid gel that is composed of a fibrous mesh and water. Hydrogels have a large water content and are typically both conductive and adhesive. Nearly all stimulating and monitoring electrodes on the market use hydrogels as the adhesive, as well as the conductive interface between the conductive electrode surface and the skin of the patient. In the case of using electrodes to stimulate metal implants in order to treat a bacterial biofilm, the hydrogel is the first electrolyte environment that the counter electrode interfaces with to create the electrochemical reaction of converting electrons in a chemical state to a purely conductive state.
  • the hydrogel will be the first layer that turns acidic from the anodic reaction. Once the hydrogel becomes acidic enough, the hydrogel will start to chemically bum the skin of the patient. Therefore and according to an aspect of the herein described electrode, the hydrogel is preferably infused with a chemical buffer that counteracts changes in local pH and incorporated in a layer 406, FIG. 4, of the electrode 400, FIG. 4.
  • the buffering compound(s) in the hydrogel that are present bind with the hydrogen ions and neutralize them. Accordingly, the pH cannot begin to decrease until the buffering capacity of the hydrogel is first depleted, thus adding yet another layer of patient safety while undergoing treatment to remove biofilm from the metal implant.
  • the initial pH of the buffered hydrogel is 7, but according to this embodiment can range from being mildly acidic (pH of 5) to fully basic (pH of 12).
  • the buffering compound used in the electrode with the hydrogel is magnesium acetate, although it will be understood that other buffering compounds can be selected.
  • a third electrode often referred to as a reference electrode in addition to the working electrode and a counter electrode.
  • a reference electrode in addition to the working electrode and a counter electrode.
  • U.S. Patent Application 62/962,524 filed January 17, 2020, and entitled: Galvanostatic Method of Microbe Removal From Surgically Implanted Orthopedic Devices, the entire contents of which are incorporated herein by reference.
  • a reference electrode is an electrode which has a stable and well-known electrode potential. This latter electrode can be adhered to the skin of the patient.
  • reference electrode potentials are used as an actual reference to compare with the applied working electrode potential.
  • the voltage will remain electrochemically stable because the reference potential is stable.
  • a fundamental behavior in potentiostatic systems, such as CVCES treatment systems, is that the resistance between the working electrode (the implant) and the reference electrode causes a certain amount of current to be driven as a result of the applied voltage. However, the current that the reference electrode dictates is driven between the working electrode and the counter electrode.
  • the resistance between a surgical implant and the reference electrode can change from patient to patient due to several factors, including skin condition and tissue composition among others. This resistance can cause inconsistencies in treatment from patient to patient because the current is what creates the therapeutic chemical reaction.
  • One way to optimize the consistency between the reference to working resistance is to insure that the reference electrode is always placed in a consistent anatomical location with respect to the metal implant.
  • the inventive electrode can contain at least one feature that is configured to align with anatomical landmarks of the body of the patient, such as the patella. The at least one alignment feature enables consistent placement zones for the reference electrode, thereby leading to provide more consistent treatment in terms of current draw.
  • FIG. 3 shows an annotated view of an idealized anatomical knee image, including an electrode made in accordance with the present invention for use in an electrochemical metal implant treatment system having three (3) separate electrodes; namely a working electrode (the metal implant 310), a counter electrode 318 and a reference electrode 330.
  • the depicted lines 314 represent the skin boundaries of the leg of a patient with the metal implant 310 being a knee replacement having tibial and femoral components.
  • the rectangle extending over the upper portion of the knee 300 represents the counter electrode 318, which similar to electrode 200, FIG. 2, is sized and configured to be circumferentially wrapped about the entirety of the leg, as shown by arrow 324.
  • the circular region shown represents the reference electrode 330, with electrical connections represented as lines 338 leading from the three (3) depicted electrodes 310, 318, 330 back to a stimulating device 340, such as a potentiostat.
  • a stimulating device 340 such as a potentiostat.
  • the illustrated circumferential counter electrode 318 has at least two (2) features that help reference electrode consistency.
  • a dotted line 350 or similarly denoted section provided on the exterior of the counter electrode 318 is an alignment aid that enables the physician to align the center of the counter electrode 318 repeatedly in line with an anatomical landmark (e.g., the patella 360) of the patient.
  • the patella 360 is an easy to identify anatomical landmark that provides a good reference for the physician though other similar landmarks can be utilized, depending, for example, on the surgical site and procedure.
  • the counter electrode 318 is provided with an identifiable placement zone or area 356 such as a cut-out area or other easily identifiable feature that provides a consistent spot for the reference electrode 330 to adhere to the skin of the patient.
  • This placement zone 356 will always be the same distance from the patellar alignment.
  • the placement zone 356 will be land on the medial side of the leg of the patient.
  • the herein described electrode may contain additional features to increase efficiency on the device side of the electrical stimulation.
  • electrodes for use in implant treatment systems are electrically attached via a single point of contact to the lead wire extending to the stimulating device.
  • a single point of contact would require the stimulating device to provide higher than typical electrical potentials to provide an adequate treatment. This behavior results from the material that the electrode is made from.
  • DC direct current
  • the conductive surface that interfaces with the hydrogel needs to be conductive, yet inert, so to not corrode as a part of the resulting anodic reaction.
  • a typical material of choice for the inert and anodic conductive layer is a carbonized rubber or carbon film. Carbon is an inert and conductive material, but is comparably less conductive than traditional conductors, such as copper.
  • the potentiostat or other suitable stimulating device In order for the electrical current from the stimulating device to spread over a larger surface area based on the larger wrappably sized electrode, as compared to the typical patch electrode 100, FIG. 1, the potentiostat or other suitable stimulating device must compensate for the losses that come from less conductive carbon by increasing the voltage to the counter electrode. Limitations in the stimulation device may not be able to provide the elevated voltage potentials required by the counter electrode in some situations, which can starve the counter electrode of electrical potential, thereby limiting the current and treatment to the implant. Therefore and to keep the counter electrode voltage requirement as low as possible, the inventive electrode preferably includes a conductive layer behind the inert conductive carbon surface layer of the electrode, which spreads the point of contact over a considerably larger area. In this specifically described embodiment, the conductive layer shown is made from a copper mesh, though this layer can alternatively be made from a solid sheet of a suitable electrically conductive material.
  • FIG. 4 a sectioned view of the various electrode layers of a portion of an electrode 400 made in accordance with an exemplary embodiment of the invention is presented.
  • the bottommost layer of the electrode 400 represents the buffered hydrogel layer 406, the adjacent layer (second from the bottom layer) represents the anodic and chemically inert conductive layer 412, the second layer from the top represents the conductive layer 416, and the top or uppermost layer of the electrode 400 represents a fabric adhesive layer 422. All of the resident layers 406, 412, 416 are preferably coextensive with the fabric adhesive layer 422.
  • an electrical connection such as provided by a lead wire 404 extending from a stimulating device (not shown in this view) attaches through the back of the fabric adhesive layer 422 to electrically connect to the conductive layer 416, which as noted previously is preferably made from copper.
  • the conductive layer 416 easily conducts the electrical potential through its surface to electrify the anodic conductive layer 412, which according to a preferred embodiment is made from a chemically inert material such as carbon. Therefore, no spot on the anodic surface layer 412 is a large distance away from where the electricity transfers from the conductive (copper) layer 416 to the anodic and inert conductive layer 412.
  • the conductive layer 416 has a thickness of 0.01- 0.02 inches to remain flexible, but the thickness of this layer can range between 0.001 to 0.1 inches.
  • the fabric adhesive layer 422 includes an adhesive backing that adheres through the openings in the conductive layer 416 to the inert conductive layer 412 in order to lock the configuration in place.
  • the lead wire 404 as shown is attached to the exterior of the flexible covering 422, wherein the configuration can alternatively be sealed between the conductive layer 416 and the covering 422.
  • the electrode is wrapped about the limb of a patient (not shown) proximate the implanted orthopedic device.
  • a stimulating device of the treatment system provides the required current and via the coupling of the coextensive conductive layer 416, electrifies the inert conductive layer 412, the latter forming the anode of the electrochemical cell created between the implant (cathode) and the electrode with the patient providing the electrolytic solution for the resulting oxidation and reduction reactions to remove biofilms from a surface of the implanted orthopedic device via the conductive interface provided by the hydrogel layer.
  • reference electrode 356 placement zone or area, reference electrode

Abstract

L'invention concerne une électrode pouvant être enroulée conçue pour être utilisée dans un système électrochimique pour traiter un dispositif métallique implanté chirurgicalement, comprenant un revêtement souple, un fil conducteur conçu pour connecter l'électrode à un dispositif de stimulation. L'électrode pouvant être enroulée comprend en outre une couche adhésive permettant la fixation de l'électrode à la peau d'un patient ainsi qu'une couche conductrice inerte à laquelle est couplé électriquement le fil conducteur. L'électrode est dimensionnée et conçue pour être enroulée autour d'une majeure partie ou, plus idéalement, autour de toute la circonférence d'un membre d'un patient à proximité du dispositif métallique implanté chirurgicalement. Selon une version, la couche adhésive de l'électrode pouvant être enroulée comprend un hydrogel tamponné ainsi qu'une autre couche conductrice servant à distribuer uniformément un courant électrique par rapport au dispositif métallique implanté lors de l'enroulement, l'électrode servant d'anode et le dispositif implanté servant de cathode dans un système de traitement CVCES. L'électrode peut en outre comprendre au moins une caractéristique permettant de garantir un placement correct de l'électrode sur la peau du patient, de même que celui d'une électrode de référence.
PCT/US2021/010004 2020-03-03 2021-02-18 Électrode pouvant être enroulée circonférentiellement destinée à être utilisée avec des implants chirurgicaux métalliques WO2021178040A1 (fr)

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WO2023064459A1 (fr) * 2021-10-13 2023-04-20 Garwood Medical Devices, Llc Système de traitement électrochimique intégré pour l'élimination d'un biofilm de dispositifs implantés
WO2023224965A1 (fr) * 2022-05-19 2023-11-23 Garwood Medical Devices, Llc Électrode d'échange de fluide et système associé

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WO2011008222A1 (fr) * 2009-07-15 2011-01-20 Philip Muccio Système pour utiliser la stimulation électrique des muscles pour augmenter le flux sanguin dans des parties du corps
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WO2023224965A1 (fr) * 2022-05-19 2023-11-23 Garwood Medical Devices, Llc Électrode d'échange de fluide et système associé

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